EP1880670B1 - Multi-lancettes - Google Patents

Multi-lancettes Download PDF

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Publication number
EP1880670B1
EP1880670B1 EP06015187A EP06015187A EP1880670B1 EP 1880670 B1 EP1880670 B1 EP 1880670B1 EP 06015187 A EP06015187 A EP 06015187A EP 06015187 A EP06015187 A EP 06015187A EP 1880670 B1 EP1880670 B1 EP 1880670B1
Authority
EP
European Patent Office
Prior art keywords
lancet
tip
tips
carrier tape
lancing
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Not-in-force
Application number
EP06015187A
Other languages
German (de)
English (en)
Other versions
EP1880670A1 (fr
Inventor
Joachim Hoenes
Volker Zimmer
Dirk Voelkel
Hans-Peter Haar
Ortrud Quarder
Hans-Jürgen KUHR
Herbert Harttig
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
F Hoffmann La Roche AG
Roche Diagnostics GmbH
Original Assignee
F Hoffmann La Roche AG
Roche Diagnostics GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to DE502006008513T priority Critical patent/DE502006008513D1/de
Application filed by F Hoffmann La Roche AG, Roche Diagnostics GmbH filed Critical F Hoffmann La Roche AG
Priority to AT06015187T priority patent/ATE491391T1/de
Priority to EP06015187A priority patent/EP1880670B1/fr
Priority to CN2007800273632A priority patent/CN101489484B/zh
Priority to CA002657453A priority patent/CA2657453A1/fr
Priority to JP2009519877A priority patent/JP2009544342A/ja
Priority to PCT/EP2007/006482 priority patent/WO2008009469A1/fr
Publication of EP1880670A1 publication Critical patent/EP1880670A1/fr
Priority to US12/356,908 priority patent/US8394035B2/en
Priority to HK10100013.1A priority patent/HK1135867A1/xx
Application granted granted Critical
Publication of EP1880670B1 publication Critical patent/EP1880670B1/fr
Not-in-force legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150442—Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
    • A61B5/150458—Specific blade design, e.g. for improved cutting and penetration characteristics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/150022—Source of blood for capillary blood or interstitial fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150175—Adjustment of penetration depth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150358—Strips for collecting blood, e.g. absorbent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • A61B5/150419—Pointed piercing elements, e.g. needles, lancets for piercing the skin comprising means for capillary action
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • A61B5/150427—Specific tip design, e.g. for improved penetration characteristics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150442—Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
    • A61B5/150465—Specific design of proximal end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150526—Curved or bent needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
    • A61B5/15148—Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
    • A61B5/15149—Arrangement of piercing elements relative to each other
    • A61B5/15153—Multiple piercing elements stocked in a single compartment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
    • A61B5/15148—Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
    • A61B5/15157—Geometry of stocking means or arrangement of piercing elements therein
    • A61B5/15159—Piercing elements stocked in or on a disc
    • A61B5/15161—Characterized by propelling the piercing element in a radial direction relative to the disc
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
    • A61B5/15148—Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
    • A61B5/15157—Geometry of stocking means or arrangement of piercing elements therein
    • A61B5/15165—Piercing elements stocked in or on a strip
    • A61B5/15169—Characterized by a rolled strip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15146—Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means.
    • A61B5/15148—Constructional features of stocking means, e.g. strip, roll, disc, cartridge, belt or tube
    • A61B5/15157—Geometry of stocking means or arrangement of piercing elements therein
    • A61B5/15165—Piercing elements stocked in or on a strip
    • A61B5/15171—Characterized by propelling the piercing element perpendicular to the direction of movement of the strip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15115—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids

Definitions

  • body fluids begins with the recovery of the fluid.
  • One method of obtaining body fluid is to create a minimal wound in the patient's skin using a needle, lancet, or knife.
  • the body fluid obtained can either be collected in small vessels or directly in contact with a test element such.
  • Most of these lancing devices require a manual insertion of the lancet in the lancing device. This is a very cumbersome handling with a very frequent use of the lancing device.
  • a magazining of lancets can solve this problem, with many safety issues to consider. It should be noted, for example, that the safety of the patient is ensured when using the lancing device. In addition, the system should not be too complex, otherwise it would not be well handled by the patient.
  • the device side setting the piercing depth is a very complicated mechanism necessary because the drive of the lancet and the lancing depth control mechanism need to be adjusted to each other.
  • the puncture depth could also be controlled by the lancets.
  • a lancet system in which a plurality of lancets are stored on a base body, which can be used individually for lancing.
  • this system also does not provide a means for selecting the puncture depth for the patient prior to the lancing process.
  • the document GB 1211432 describes a lancet that has two lancet tips of different lengths so that the lancet can be used for both children and adults.
  • the invention relates to a device for obtaining body fluids, which has at least one lancet, comprising a lancet body having at least two tips of different lengths.
  • the device is characterized in that it has a means for selection, by means of which only one tip is selected before the puncture.
  • This selection means may have various functions and shapes.
  • the means for selection serves to select a tip from a plurality of lancet tips having different lengths and to provide only that selected tip for use in the lancing process. Since the lancet tips have different lengths, the lancing depth can be adjusted by the choice of the lancet tip to be used for the lancing process.
  • the selected lancet tip and the other lancet tips are arranged so that only the selected lancet tip penetrates into the body to be stung.
  • This device for recovering body fluid has the advantage that the device itself no further control of the puncture depth must be made, as in the prior art (eg WO 20060380449 ) the case is. This requires no special Tuning of the drive with the device-side puncture depth control. On the device itself no adjustable parts need to be attached and adjusted. As a result, inexpensive drives and housings can be used. In the device described here, the selection of the piercing depth therefore takes place via the selection of the lancet tip. This means that several lancet tips with different lengths must be provided. These different lengths lancet tips are arranged on a lancet body. The type of arrangement can include all possible shapes and geometries.
  • the single tip can be used by moving the lancet body so that only one lancet tip points in the direction of the piercing body as the lancet body moves.
  • the other lancet tips point in other directions and consequently are not pierced into the body during the insertion process.
  • This arrangement of selected and unselected tips can be realized by different geometries of the lancet body in different ways. For this purpose, various means for selection are necessary.
  • This selection means may include, for example, a label on the lancet itself or on the lancet body.
  • a marking can be recognized, for example, optically, mechanically or electrochemically in the device.
  • a sensor can be used which makes it possible to perform an optical, mechanical or electrochemical registration of the arrangement of the lancet body in the device.
  • This marking may, for example, be a notch or else a coloring of a part of the lancets or of a possible carrier if the lancet is applied to a carrier.
  • the means for selection may be a device that allows the lancet body to be positioned so that the selected lancet tip is provided for use so that it can interact with a drive unit to move to the puncture.
  • This may be, for example, the same device that is also used for further indexing the lancet body.
  • the lancet body is moved further by a lancet tip. This can be displayed to the user via a counter, so that it is always apparent to the user which lancet length is currently provided for the puncture. It should be prevented that the device can be clocked back so that no repeated use of a lancet tip is possible.
  • any other type of selection is also possible, which makes it possible to ensure a positioning of the lancet body in order to select a single lancet tip for use and to position the puncture so the drive unit, without that more than one lancet tip is used.
  • a marking of optical or mechanical nature can be made as described above.
  • Further possibilities for marking the lancet body are a different magnetization or different impedance of different regions of the lancet body or of the lancet tips.
  • the device requires an optical detection means, such as an optical sensor.
  • the positioning of the selected and selected lancet tip or lancet body with respect to the Drive unit on the one hand and the puncture meant. It should thus be ensured that the selected lancet tip can be moved by the drive unit so that a puncture can be made on the part of the body provided for the puncture.
  • the lancet may be positioned so accurately in the device that only by rotation and / or displacement of the lancet body or carrier the selected lancet tip can be provided for use ,
  • a kink element may be used which kinks one of the various tips from the lancet body plane. This is particularly preferred in the case of lancet tips that are arranged linearly relative to one another.
  • the buckling element forms the means for selection. The kinking makes it possible, upon movement of the lancet body to the puncture, to move only the kinked lancet in the direction of the body part to be staked. The kinking is thus prevented that more than one lancet tip penetrates into the body.
  • the lancet body thus has a plurality of coupling elements, which enable a coupling of the lancet to the drive unit at different locations of the lancet body. Depending on the selected coupling element is carried out according to a selection of the lancet tip, which is to be used for a lancing process. In the described embodiment, therefore, the coupling elements are part of the means for selection.
  • the lancet should have special material properties.
  • the lancet can be a flat lancet and / or have a kink area.
  • the lancet is a flat lancet and has a kink area.
  • the lancet body is also designed flat.
  • the kink region of the lancet which may also be outside the tip region, has at least one structure with modified rigidity. This at least one structure with modified rigidity is referred to below as embossing.
  • the embossing can be achieved by z. As etching, punching or hammering or other metal-working measures are worked in or on the lancet.
  • the stiffness can thus be adjusted preferably by the variation of the geometry of the lancet or by the variation of the amount of material for the production of the lancet.
  • a preferred embodiment includes more than one embossment in the kink region of the lancet.
  • a particularly preferred embodiment of this embossment is a triple embossing in the bending region of the lancet, which extends over at least part of the longitudinal extent of the lancet.
  • An embossing extends from the distal end of the lancet in the axial direction in the direction of the proximal end of the lancet. The length of the embossing is variable. This embossing can be introduced from two sides in the flat lancet.
  • This different direction of embossing causes the lancet tip to bend in the opposite direction to the lancet body.
  • the bent surfaces are lifted at an angle of preferably up to 100 ° from the lancet body plane.
  • the lancet tip is moved out of the plane of the lancet body.
  • the transmission of the force to the lancet can take place by a buckling element, for example a plunger, which is pressed onto the lancet.
  • a buckling element for example a plunger
  • it is possible to transfer the force to the lancet by, for example, guiding the lancet body with the lancet tip over the plunger or pushing the plunger against the lancet tip.
  • a sufficiently large force acts on the lancet in order to move the lancet tip out of the lancet body plane.
  • the lancet body is a carrier tape or if the lancet body is fixed on a carrier tape, then it may be necessary to bend the lancet tip back into the carrier tape plane after the puncture in order to enable Remagazinleiter.
  • a return element can be used, which transfers the lancet tip back into its original position before kinking after the puncture, as shown in the Figures 8 ad shown is.
  • the Remagazinleiter done due to the material properties of the lancet.
  • the lancet may be made of a shape memory material, such as Nitinol, which flexes in the cool state (such as room temperature) and the curved shape is maintained until heated. This rebreathing temperature is between 34-60 ° C depending on the alloy.
  • a preferred embodiment for the arrangement of different lengths of lancet tips is a lancet wheel.
  • circular lancets are arranged in a plane having different long lancet tips, or whose lancet tips are bent at different locations in order to vary the length of the lancet tip.
  • the lancet tip can also be designed in the form of a cutting edge.
  • the material of the lancet is preferably metal, more preferably steel.
  • the lancet can also consist of other materials and material combinations.
  • the material should be of the shape that it can be worked at the distal end of the lancet tip to a sharp point, otherwise the stitch is too much pain generated.
  • the manufacture of lancets in general is well known in the art, such as in US Pat DE 19604156 or EP 0565970 , If the lancet is kinked prior to lancing, the material of the lancet should be such that the lancet is kinkable upon application of force and yet has sufficient rigidity to penetrate the skin during use without altering its shape.
  • the lancet body is worked together with the lancet tips in one piece. This can be produced, for example, by etching or punching the steel lancet.
  • the device can only drive a lancet, or the device can be combined in a system with other elements, such as test elements, detectors, evaluation units and display units.
  • a plurality of lancet bodies having a plurality of test elements are arranged on or on a carrier tape.
  • the carrier tape can act here as a lancet body.
  • the lancet may be fixed to the carrier tape at its proximal end such that a portion of the lancet may be moved in relation to or with the carrier tape while the proximal end is in contact with the carrier at least at one point Carrier tape is connected.
  • the controlled movement of the lancet can be done by moving the carrier tape or by gripping the lancet with a gripping element, wherein the lancet tip is moved out of the plane of the carrier tape with the carrier tape.
  • This movement can be carried out by means of a drive element which transmits power perpendicular to the carrier belt plane to the lancet.
  • the power transmission takes place by a drive element, which may be, for example, a plunger or a gripping element which engages and moves the lancet on its lancet body.
  • the penetration depth of the blood sampling device is freely selectable.
  • a preferred embodiment for driving the lancet is the free movement of the lancet after power transmission by the drive element, such as the plunger.
  • a pulse is transmitted from the drive element to the lancet and the lancet moves without further guidance by the drive element in the direction of the housing opening. The movement of the lancet can be performed by additional elements on the housing.
  • the lancet at least the tip area of the lancet is protected by a sterile barrier.
  • This sterile protection may be a film which additionally contains an antibacterial agent such as silver.
  • the lancet over the entire lancet body is covered with this film as a sterile protection.
  • the film may, when using a carrier tape over a portion of the carrier tape extend and be connected.
  • This sterile protection can consist of a polymer layer which is applied after the production of the lancet. This polymer layer is destroyed or punctured by the lancet tip as it applies the threshold force to the lancet tip and exposes the lancet tip.
  • the sterile guard may be removed prior to use of the lancet.
  • the sterile protection is hereby removed as a whole.
  • the lancet has at least in its tip region a channel which serves to collect blood from the wound with the lancet.
  • a microsampler This embodiment is referred to below as a microsampler.
  • the blood collected in the microsampler can then be transferred to a test element and detected by a detection system (eg, optically or electrochemically) and evaluated by an evaluation system.
  • the invention furthermore relates to a lancet for piercing a body part.
  • the lancet body has at least two tips which have different lengths.
  • the lancet is designed such that a tip is selectable, so that a lancing process with a defined puncture depth depending on the length of the selected tip can be done.
  • the unselected tips are positionable relative to the selected tip during a piercing operation such that a piercing operation is performed exclusively with the selected tip, while the unselected tip is not involved in the piercing process. In this way, a regulation of the penetration depth by the selection / selection of a specific tip of the lancet is possible.
  • a lancet tip can be selected by kinking a tip, the lancet having a kink area for this purpose, as already described.
  • a plurality of coupling elements of a lancet are conceivable, so that a selection of a tip is made by selecting a corresponding coupling element.
  • the coupling element of the lancet is then simultaneously a component of a means for selection, as has already been shown several times.
  • various embodiments of a coupling element are conceivable which advantageously simultaneously enable selection of a lancet tip.
  • the lancet according to the invention may additionally contain selection means, as already described.
  • markings of the respective lancet tips may be mentioned here, which permit a targeted selection of a lancet tip, for example by means of an optical detection of the marking, in a corresponding device and thus allow a selection of the penetration depth.
  • the means for selection are both part of the device and the lancet itself, with a corresponding interaction between the device and lancet allows selection of a lancet tip.
  • the device can be combined with other different elements for analyzing a body fluid (eg, test element, detector, evaluation unit, etc.).
  • a system with a carrier tape will be described, but not limited to the selection of elements in a system.
  • This system preferably consists of a housing in which a substantially planar carrier tape is mounted, and at least two lancets, which are arranged lying on the carrier tape.
  • the housing has at least one opening, to which the lancet is moved during the lancing process and, if necessary, can pass through it.
  • the substantially planar carrier tape is preferably wound on two spools. But it can also be used other storage options for magazining the used and unused lancets. When using two lancet storage magazines, the unused lancets are on one spool and the used lancets are on the other spool.
  • the lancets are made of a material that is soft enough to be wound on the carrier tape without kinking.
  • the lancet material is so stable that the lancet will not be deformed upon actuation and entry into the skin.
  • the lancets are arranged transversely on the carrier tape so that bending of the lancet can be avoided.
  • Another way to avoid bending the unused lancets is to choose the diameter of the spool on which the lancets are stored, so that the lancets are hardly bent when rolled up.
  • the lancet has at least two lancet tips located on the lancet body.
  • the means of selection in this case a buckling element
  • the lancet is thus selected by kinking.
  • the buckling element which acts on the lancet so, the lancet tip is variable with respect to the rest of the lancet body in their orientation.
  • the buckling element can, when force is applied to the lancet before the actuation, regulate the location of the force on the lancet body.
  • the buckling element can be controlled by a control element.
  • Conventional lancets can be used in the system, preferably the lancets are shaped as flat lancets.
  • the lancet is moved by a drive element in the direction of the housing opening in order to exert the lancing process there. In the case of the bent lancet tip, this may take place after or during this bending process. In this case, at least a part of the lancet moves in the direction of the housing opening and pierces the skin of the patient.
  • a drop of blood forms, which is used for analysis. If a test element is on the carrier tape, the carrier tape is transported so far if necessary, that the test element is located below the housing opening. The blood drop can be applied to the test element without the patient having to take further steps.
  • the blood reacts with one or more reagents located on the test element, such as those shown in FIG. B. from the documents EP-A 0 885 591 . EP-B 0 535 480 and EP-B 0 477 322 are known.
  • the test element is analyzed by means of a detector.
  • the blood can be assayed for various components as known in the art.
  • the analysis may be directed to blood components such as hematocrit, glucose, cholesterol, coagulation, iron and others.
  • Different methods can be used for the analysis.
  • electrochemical detection reactions can be used, but also optical (eg reflection, absorption, fluorescence, Raman spectroscopy) or magnetic detection reactions.
  • the liquid is contacted with a test system with reaction between a test element and the liquid.
  • detection by means of an optical test element is based on a color reaction between the liquid and the detection reagent. Examples of these reactions are in the U.S. Patents 3,802,842 ; 4,061,468 and 4,490,465 described.
  • test element is after the lancing process transported to the housing opening to receive the drop of blood for analysis.
  • the test element can be transported to the detector and measured there.
  • a lancet (1) is shown, which consists of a lancet body (2) and at least 2 lancet tips (3).
  • a portion of the lancet tips (3) are located on one side of the lancet body (2) shown here rectangular and the remaining part of the lancet tips (3) on the opposite side of the lancet body (2).
  • a plurality of 100 lancets may be arranged.
  • up to 100 lancet tips (3) are arranged on the lancet body, which can then be wound on a belt, for example.
  • lancet tips (3) are arranged on the lancet body (2), wherein the lancet bodies can then be arranged in a stack in a magazine.
  • the carrier tape serves as a lancet body on which the lancet tips are arranged.
  • This carrier tape may for example consist of fabric, or else be a metal band.
  • the means for selection that is to say the selection of the lancet length and thus of the puncture depth, can in this case be a device element which serves to further index the device.
  • a precisely adjusted mechanism advances the tape from one lance tip to the next during each cycle. For this purpose, the lancet tips must be precisely arranged.
  • the lancet body is moved further by a lancet tip. This can be displayed to the user via a counter, so that it is always apparent to the user which lancet length is currently provided for the puncture. It should be prevented that the device is clocked back so that no repeated use of a lancet tip is possible.
  • the lancet is rotatably connected to the drive unit, so that due to a rotation of the plunger and thus the lancet a desired tip for a lancing process can be selected. In this way, a selection of a lancet tip is possible due to the interaction of the drive unit with the coupling element of the lancet.
  • the lancet tips (3) have a kink at their proximal end (3a) which adjoins the lancet body (2). By this kink, the lancet tip (3) from the plane of the body and the remaining lancet tips are Grangeknickt, whereby a selection of the desired lancet tip (3) can take place.
  • the lancing process (1) is used to puncture the entire lancet.
  • FIG. 3 a section of a lancet (1) is shown, wherein the lancet tip (3) shown here, which is located on the lancet body (2), a region having a plurality of fold lines (4a, b, c).
  • the crease line (4a) extends from the distal end 3b of the lancet tip (3) in the direction of the proximal end (3a) of the lancet tip (3).
  • This bending line (4a) may extend over the entire tip region of the lancet tip (3) or only over a partial region of the lancet tip (3).
  • crease lines (4b and 4c) may extend laterally from the first crease line in the direction of the proximal end (3a) of the lancet tip (3).
  • FIG. 4 shows a lancet tip (3) with an integrated microsampler (5).
  • the lancet tip (3) with integrated microsampler (5) can be bent over a bending line (4a) at the proximal end (3a) of the lancet tip (3).
  • FIG. 5 shows a particular embodiment of the lancet tip (3) with integrated microsampler (5), wherein, as in FIG. 3 several crease lines (4a 4b and 4c) are located.
  • FIG. 6 shows a system with a carrier tape (10) which is wound on two different rollers (11a and 11b), wherein one of the rollers (11a) may contain unused lancets (1) or test elements (13) while using roller (11b) Lancets (1) or test elements are stored.
  • the system may further comprise a buckling element (12) which, after selection of the corresponding lancet tip (3), the lancet kinks.
  • the buckling element serves as a means for selection.
  • the system may include optics and means for driving the lancet, such as a plunger. The optics can also serve as means for selection, if this is designed as a sensor for a marking on the carrier tape (10) or the lancet body (2) with lancet tips (3)
  • Figure 7a shows a circular arrangement of lancet tips (3) and lancet carriers (23) in the form of a lancet wheel (24).
  • the lancet tips (3) to the lancet carriers (23) can be bent and thereby also have different lengths.
  • the lancet carriers (23) can be separated from each other by grooves, so that each lancet arm (25) can be deflected out of the plane of the circular lancet (1). This can be used to execute the lancing process.
  • the lancet arm (25) makes a circular movement during the puncture.
  • the lancet arm (25) may have webs that limit the depth of penetration, as they prevent further penetration of the lancet when punctured in the body.
  • the lancet moves back to the original position after the puncture by itself, as in FIG. 9
  • the lancet arm (25) can be deflected both up and down due to its flexibility. Since the lancet arm (25) makes a circular movement during the piercing movement, the user's body is not pierced vertically but in a circular motion. This has the consequence that not only force is applied perpendicular to the skin but also lateral forces act. As a result, the pain during puncture is greater than with a conventional lancet, which is inserted vertically into the skin.
  • the lancet tip (3) of the lancet (1) can have a cutting edge (70) which cuts through the skin of the body and does not puncture the skin, as in conventional lancets.
  • a lancet (1) is shown having a cutting edge at its distal end (3b).
  • the cutting edge in contrast to a lancet tip (3), (as shown in the preceding figures) does not have edges which run uniformly towards each other and unite in the tip (3).
  • the edges and the cutting edge converge at different angles to the tip.
  • the first side edge and the second side edge may run in the plane of the circular path or transversely thereto.
  • the side edges arranged in the plane of the circular path do can cut the ground side edges in the direction of movement, while the arranged transversely to the circular path side edges also cross across the direction of movement, which can lead to more pain during puncture.
  • a similarly configured wheel such as the lancet wheel (24), may also be configured for test elements that may be arranged in a system with the lancet wheel (24) such that puncture and blood carryover may be performed at an opening.
  • a device is shown schematically, which ensures the kinking before the puncture and the bending back after the puncture.
  • This device is preferably to be used with lancets mounted on a carrier tape (10). But it can also be used for lancets that are not mounted on a carrier tape (10).
  • the lancet (1) is to be bent out of the carrier band plane. This condition is in FIG. 8a shown.
  • the carrier tape (10) between the lower part (82) and the upper part (81) of the holding element (80) and the slider (89) is clamped. As a result, a part of the carrier tape (10) is folded over and thereby slipping during the buckling process is prevented.
  • the lancet (1) is bent at a predefined location with the aid of a transfer element (84), which is driven by a plunger (85).
  • the Umlegeelement (84) exerts in this process so much pressure on the lancet, that it kinks at the point where it touches the upper part (81) of the holding element (80), as in FIG. 8b shown.
  • the holder of the carrier tape (10) by the holding element (80) is released after the buckling and the holding element (80) can be rotated out of the carrier band level, so as not to hinder the lancing process.
  • the lancet (1) can be moved by moving the slider to the puncture.
  • the holding element (80) is connected to a carriage (88) which is able to displace the holding element (80), which serves as a reference element for adjusting the puncturing depth.
  • the carriage (88) By moving the holding element (80), the upper part (81) of the holding element (80) pushes more or less far over the carrier tape (10) towards the lancet tip.
  • the displacement of the carriage (88) can preferably be done by a sliding thread (87).
  • a Be bent back element (86) be mounted so that after the puncture of the lancet (1) in the body, the lancet (1) bends back into the carrier band plane.

Claims (24)

  1. Dispositif d'obtention de liquide corporel, comportant :
    au moins une lancette (1) comprenant un corps de lancette (2) doté d'au moins deux pointes (3) présentant des longueurs différentes, ainsi qu'une unité d'entraînement pour déplacer la lancette,
    caractérisé en ce que le dispositif possède un moyen de sélection à l'aide duquel une pointe (3) est sélectionnée, ledit moyen de sélection permettant de positionner le corps de lancette de façon à ce que la pointe de lancette sélectionnée soit mise à disposition pour l'emploi de sorte qu'elle puisse interagir avec l'unité d'entraînement pour être déplacée vers la piqûre, permettant ainsi d'effectuer une piqûre de profondeur définie dans une partie du corps appliquée contre le dispositif, en fonction de la longueur de la pointe sélectionnée (3), au moins une des pointes non sélectionnées étant positionnée de telle façon dans le dispositif pendant une piqûre que la pointe non sélectionnée ne puisse être utilisée pour effectuer une piqûre.
  2. Dispositif selon la revendication 1, caractérisé en ce que lesdites au moins deux pointes sont disposées selon des directions différentes sur le corps de lancette.
  3. Dispositif selon la revendication 1 ou 2, caractérisé en ce que lesdites au moins deux pointes sont disposées en étoile sur le corps de lancette.
  4. Dispositif selon la revendication 1, caractérisé en ce que lesdites au moins deux pointes sont disposées de façon linéaire sur le corps de lancette.
  5. Dispositif selon une des revendications 1 à 4, caractérisé en ce que le dispositif possède un dispositif de pliage ayant pour effet de modifier l'orientation des pointes par rapport au corps de lancette.
  6. Dispositif selon une des revendications 1 à 5, caractérisé en ce qu'au moins une pointe est modifiable quant à son orientation par rapport au corps de lancette.
  7. Dispositif selon une des revendications 1 à 6, caractérisé en ce que ladite au moins une lancette est une lancette plate.
  8. Dispositif selon une des revendications 1 à 7, caractérisé en ce que lesdites au moins deux pointes présentent une zone pliée possédant au moins une structure de rigidité modifiée.
  9. Dispositif selon une des revendications 1 à 8, caractérisé en ce qu'au moins une structure de rigidité modifiée s'étend sur une partie de l'extension longitudinale de la zone de pointe.
  10. Dispositif selon une des revendications 8 ou 9, caractérisé en ce que ladite au moins une structure de rigidité modifiée a pour effet une pliure des surfaces adjacentes.
  11. Dispositif selon une des revendications 1 à 10, caractérisé en ce que la lancette est disposée sur une bande support.
  12. Dispositif selon la revendication 11, caractérisé en ce que ladite au moins une lancette est disposée selon des orientations différentes sur la bande support.
  13. Dispositif selon la revendication 11 ou 12, caractérisé en ce qu'au moins un élément de test est encore disposé sur la bande support.
  14. Dispositif selon une des revendications 11 à 13, caractérisé en ce que la lancette est fixée à son extrémité proximale sur la bande support.
  15. Dispositif selon une des revendications précédentes, caractérisé en ce qu'au moins les pointes de lancette possèdent une protection stérile.
  16. Dispositif selon une des revendications précédentes, caractérisé en ce que le dispositif possède un moyen permettant de replier les pointes pliées.
  17. Dispositif selon une des revendications précédentes, caractérisé en ce que le dispositif présente un élément de test.
  18. Dispositif selon une des revendications précédentes, caractérisé en ce que le dispositif présente une unité de détection.
  19. Lancette (1) destinée à piquer une partie du corps, comportant:
    un corps de lancette (2) doté d'au moins deux pointes (3) présentant des longueurs différentes,
    la lancette (1) étant conçue de telle façon qu'une pointe (3) puisse être sélectionnée parmi lesdites au moins deux pointes, permettant ainsi d'effectuer une piqûre de profondeur définie en fonction de la longueur de la pointe sélectionnée, et la pointe de lancette sélectionnée ainsi que les autres pointes de lancette étant disposées de telle manière que seule la pointe de lancette sélectionnée puisse pénétrer dans le corps à piquer pendant une piqûre, et au moins une des pointes non sélectionnées est positionnée pendant une piqûre de telle façon par rapport à la pointe sélectionnée que la pointe non sélectionnée ne puisse être utilisée pour effectuer une piqûre,
    caractérisée en ce que le corps de lancette (2) est une bande support ou en ce que le corps de lancette (2) est fixé sur une bande support.
  20. Lancette selon la revendication 19, caractérisée en ce qu'une zone pliée prévue dans la lancette permet de sélectionner une pointe.
  21. Lancette selon la revendication 19 ou 20, caractérisée en ce que la lancette présente un élément de couplage permettant d'accoupler la lancette à une unité d'entraînement d'un système de prélèvement sanguin.
  22. Lancette selon la revendication 21, caractérisée en ce que l'élément de couplage permet un accouplement de la lancette selon différentes positions par rapport à l'unité d'entraînement.
  23. Lancette selon la revendication 21, caractérisée en ce que la lancette présente plusieurs éléments de couplage.
  24. Lancette selon la revendication 21, caractérisée en ce que les pointes de lancette présentent des orientations différentes sur le corps de lancette.
EP06015187A 2006-07-21 2006-07-21 Multi-lancettes Not-in-force EP1880670B1 (fr)

Priority Applications (9)

Application Number Priority Date Filing Date Title
AT06015187T ATE491391T1 (de) 2006-07-21 2006-07-21 Multilanzetten
EP06015187A EP1880670B1 (fr) 2006-07-21 2006-07-21 Multi-lancettes
DE502006008513T DE502006008513D1 (de) 2006-07-21 2006-07-21 Multilanzetten
CA002657453A CA2657453A1 (fr) 2006-07-21 2007-07-20 Lancettes multipointes
CN2007800273632A CN101489484B (zh) 2006-07-21 2007-07-20 多柳叶刀装置
JP2009519877A JP2009544342A (ja) 2006-07-21 2007-07-20 複数ランセット装置
PCT/EP2007/006482 WO2008009469A1 (fr) 2006-07-21 2007-07-20 LancetteS multipointes
US12/356,908 US8394035B2 (en) 2006-07-21 2009-01-21 Multi-lancet device
HK10100013.1A HK1135867A1 (en) 2006-07-21 2010-01-04 Multi-lancet device

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP06015187A EP1880670B1 (fr) 2006-07-21 2006-07-21 Multi-lancettes

Publications (2)

Publication Number Publication Date
EP1880670A1 EP1880670A1 (fr) 2008-01-23
EP1880670B1 true EP1880670B1 (fr) 2010-12-15

Family

ID=37402521

Family Applications (1)

Application Number Title Priority Date Filing Date
EP06015187A Not-in-force EP1880670B1 (fr) 2006-07-21 2006-07-21 Multi-lancettes

Country Status (9)

Country Link
US (1) US8394035B2 (fr)
EP (1) EP1880670B1 (fr)
JP (1) JP2009544342A (fr)
CN (1) CN101489484B (fr)
AT (1) ATE491391T1 (fr)
CA (1) CA2657453A1 (fr)
DE (1) DE502006008513D1 (fr)
HK (1) HK1135867A1 (fr)
WO (1) WO2008009469A1 (fr)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW201216924A (en) * 2010-07-08 2012-05-01 Sanofi Aventis Deutschland Apparatus including a lancet
TW201206400A (en) * 2010-07-08 2012-02-16 Sanofi Aventis Deutschland Allowing measurements to be made of a blood sample
DE102011015901B3 (de) * 2011-04-01 2012-07-26 Gerresheimer Regensburg Gmbh Stechhilfevorrichtung geeignet für eine Blutprobenentnahme
CN110464420B (zh) * 2019-08-13 2021-04-02 郑州大学第一附属医院 用于心血管治疗的介入装置

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SE360973B (fr) * 1970-09-23 1973-10-15 Forsheda Ideutveckling Ab
US4418703A (en) * 1981-07-30 1983-12-06 Becton Dickinson And Company Multiple sample needle assembly
DE3208391A1 (de) * 1982-03-09 1983-09-22 Werner 7735 Dauchingen Beiter Blutlanzette
US4794926A (en) 1986-11-24 1989-01-03 Invictus, Inc. Lancet cartridge
JP3638958B2 (ja) * 1995-07-28 2005-04-13 アプルス株式会社 ランセットの刺通深さを調節するためのアッセンブリ
US6139562A (en) * 1998-03-30 2000-10-31 Agilent Technologies, Inc. Apparatus and method for incising
US6022366A (en) * 1998-06-11 2000-02-08 Stat Medical Devices Inc. Lancet having adjustable penetration depth
US6132449A (en) * 1999-03-08 2000-10-17 Agilent Technologies, Inc. Extraction and transportation of blood for analysis
US6306152B1 (en) * 1999-03-08 2001-10-23 Agilent Technologies, Inc. Lancet device with skin movement control and ballistic preload
US6322575B1 (en) * 2000-01-05 2001-11-27 Steven Schraga Lancet depth adjustment assembly
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US6726649B2 (en) * 2001-12-28 2004-04-27 Becton, Dickinson And Company Medical needle assemblies
JPWO2003084401A1 (ja) 2002-04-04 2005-08-11 松下電器産業株式会社 ランセットデバイス
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Also Published As

Publication number Publication date
US20090177118A1 (en) 2009-07-09
WO2008009469A1 (fr) 2008-01-24
CA2657453A1 (fr) 2008-01-24
US8394035B2 (en) 2013-03-12
JP2009544342A (ja) 2009-12-17
CN101489484B (zh) 2012-11-14
ATE491391T1 (de) 2011-01-15
HK1135867A1 (en) 2010-06-18
EP1880670A1 (fr) 2008-01-23
DE502006008513D1 (de) 2011-01-27
CN101489484A (zh) 2009-07-22

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